Calendula officinalis, ext.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study carried out between the 29 February 2016 and 21 March 2016.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Calendula officinalis, ext.

EC Number:

283-949-5

EC Name:

Calendula officinalis, ext.

Cas Number:

84776-23-8

Molecular formula:

UVCB substance, not relevant.

IUPAC Name:

Calendula officinalis, ext.

Test material form:

liquid

Specific details on test material used for the study:

Teinture mère de Calendula officinalis – code C19F. Batch No.: M4080014

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three male albino New Zealand rabbits were supplied by EUROLAP. The animals were kept during a minimal 5-day acclimatisation period.
At the beginning of the test, the animals were 10 or 11 weeks old.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

at the dose of 0.1 mL.

Duration of treatment / exposure:

Initially, a single animal was treated. After consideration of the responses in the first animal, two additional animals were treated in the same experimental conditions.

Observation period (in vivo):

Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: days 2 and 3

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

48 h

Score:

0

Reversibility:

fully reversible within: days 2 and 3

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

72 h

Score:

0

Reversibility:

fully reversible within: days 2 and 3

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

2

Reversibility:

fully reversible within: days 2 and 3

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

48 h

Score:

1

Reversibility:

fully reversible within: days 2 and 3

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

72 h

Score:

0

Reversibility:

fully reversible within: days 2 and 3

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24 h

Score:

2

Reversibility:

fully reversible within: days 2 and 3

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

48 h

Score:

0

Reversibility:

fully reversible within: days 2 and 3

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

72 h

Score:

0

Reversibility:

fully reversible within: days 2 and 3

Irritant / corrosive response data:

The ocular reactions observed during the study have been slight to moderate and totally reversible:
- at the conjunctivae level: a slight to moderate redness noted 24 hours after the test item instillation and totally reversible between days 2 and 14; associated with a slight chemosis noted 1 hour after the test item instillation in two animals and totally reversible between days 2 and 3.
- at the iris level: an injection noted at the reading time 1 hour in one animal and at the reading time 24 hours in a second animal.
- at the corneal level: a slight to moderate opacity, noted 24 hours after the test item instillation and totally reversible between days 2 and 3.
Whitish secretion requiring a physiological saline rinse was noted in one animal on day 1.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item Teinture mère de Calendula officinalis – code C19F does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No symbol and warning label are required.